Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.
Interventions
DEVICEPortable Oxygen Cylinder
A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
DEVICEMobi
ResMed's variant of POC
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a prospective, randomized, cross-over study design with participants serving as their own controls. A within- participants, repeated-measures design is used during 6MWT. Eligible participants will complete two 6MWTs: one with their usual portable oxygen cylinder, and one with Mobi™. All participants entered into the study will be randomized in a 1:1 ratio to the following order of device use: * Control device (portable oxygen cylinder) first; or * Study device (Mobi™, POC) first.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male or female, age ≥ 18 years at the time of signing informed consent. 3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22). 4. Current prescription for long-term oxygen therapy. 5. Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise. 6. Participants who can read and comprehend English.
Exclusion criteria
1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol. 2. Current oxygen therapy prescription for \>5 L/min continuous flow. 3. Known or suspected contraindication for pulse-dose oxygen. 4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month 5. Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) | Mean Sp02, measured during 6 minute walk test | Each subject's SpO2 will be measured when each subject takes six minutes walk test |
Countries
United States
Participant flow
Pre-assignment details
Participants acted as their own controls. Participants were randomised as to the order they used the devices during the 6-minute walking test. There was a one hour wash out period between tests
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 69.86 years STANDARD_DEVIATION 8.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
Each subject's SpO2 will be measured when each subject takes six minutes walk test
Time frame: Mean Sp02, measured during 6 minute walk test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portable Oxygen Cylinder | Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) | 91.2 percentage of oxygen saturation | Standard Error 0.7 |
| Mobi™ Portable Oxygen Concentrator | Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) | 90.0 percentage of oxygen saturation | Standard Error 0.7 |